FDA clearance for ECG-AI cardiac amyloidosis detection
FDA 510(k) clearance (K253801)
The cardiac amyloidosis algorithm received FDA 510(k) clearance — the first and only one cleared to detect the disease from a standard 12-lead ECG.
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- Problem
- Cardiac amyloidosis is a rare, under-diagnosed heart disease, while a standard 12-lead ECG is routine and widely available.
- My role
- Led development of the ECG-AI model at nference with Pfizer, then owned the scientific deliverables of the FDA 510(k) submission at Anumana — clinical validation analyses, technical reports and responses to FDA questions.
- Result
- FDA Breakthrough Device Designation (2023), selection for the FDA TAP pilot, and 510(k) clearance in April 2026 — the first for this indication using a standard 12-lead ECG.